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Effectiveness of Scapular Clock Exercises in Scapular Dyskinesia in Post-Operative Open Heart Surgery Patients

Primary Purpose

Scapular Dyskinesis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Scapular clock exercises
Stretching and strengthening exercises
Sponsored by
University of Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scapular Dyskinesis focused on measuring Scapular dyskinesia, Scapular Clock Exercises, Open Heart Surgery

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients whose open heart surgery is done at least 6weeks ago.
  • Subjects having shoulder and scapular region pain.
  • 50% or less loss of Active ROM of shoulder in abduction, flexion and external rotation.
  • Positive Scapular assistance (SAT) and Scapular retraction test.
  • Positive findings on observational examination of scapula, showing abnormal prominence of either inferior, medial or superior border of scapula.
  • Type I and Type II scapular dyskinesia present
  • Consented to take part in the study.

Exclusion Criteria:

  • • Bilateral shoulder involvement

    • History of previous surgery on shoulder
    • Shoulder fracture
    • Glenohumeral or acromioclavicular joint Arthritis.
    • Neuromuscular disorders

Sites / Locations

  • Faisalabad Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

The interventional group received stretching and strengthening exercises along with scapular clock exercises. For the first two weeks, only scapular clock exercises were performed by the patient actively. After 2 weeks, the subjects performed scapular clock exercises by using the thera-band.

The active control group received stretching and strengthening exercises only. The stretching and strengthening exercises include corner stretch, wall-washes and pectoralis minor muscle stretch.

Outcomes

Primary Outcome Measures

Shoulder pain
Shoulder pain was assessed by using the Numeric Pain Rating (NPRS) Scale. NPRS is an 11-item Likert scale having 0 as no pain and 10 as maximum pain

Secondary Outcome Measures

Level of Shoulder activity limitation
The level of shoulder activity limitation was assessed by using the Quick-DASH questionnaire. There were 11 questions that were rated by the Likert scale having 1 as no disability and 5 as maximum disability

Full Information

First Posted
May 25, 2022
Last Updated
June 20, 2022
Sponsor
University of Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05426694
Brief Title
Effectiveness of Scapular Clock Exercises in Scapular Dyskinesia in Post-Operative Open Heart Surgery Patients
Official Title
Effectiveness of Scapular Clock Exercises in Scapular Dyskinesia; A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In patients after open-heart surgery, the complaint of scapular dyskinesia is very common. It occurs due to the weakness of the muscles surrounding the scapula. In this research, investigators checked the effectiveness of scapular clock exercises in scapular dyskinesia, in post-op open heart surgery patients. There were two groups, an intervention "Active group" and a 'control group'. The patients will be randomly assigned to each group equally. The treatment session was given for a period of 4 weeks, with 3 sessions each week. They were assessed before treatment, after 2 weeks and post-intervention.
Detailed Description
Scapular dyskinesia is the malalignment of the scapula. It occurs when the pectoralis muscle (pectoralis minor) becomes tight and there is the weakness of the trapezius muscle (lower fibers). It can commonly occur after open-heart surgery due to incision and prolonged bed rest. In this research, the effectiveness of scapular clock exercises was checked. These exercises can strengthen the weak trapezius muscle and also stretch the tight pectoralis minor muscle. By adding these exercises in cardiac rehabilitation the occurrence of scapular dyskinesia can be reduced. Post-op open heart surgery patients mostly present with complain of shoulder pain. Most of their treatment is directed towards shoulder joint while the scapula is usually ignored. So it is important to add exercises directed towards the scapula along with shoulder. In this study, The investigators will recruit 30 post-op cardiac surgery patients with complain of shoulder pain, with positive scapular dyskinesia. The sample size was calculated using formula and the values were taken from previous researches. Scapular assistance test and Scapular retraction test was used to find out patients with scapular dyskinesia. The subjects will then be randomly divided into two groups using online randomization generator. The interventional group was receive stretching and strengthening exercises with additional scapular clock exercises and the active control group will receive stretching and strengthening exercises. There was 3 sessions per week, for a period of 4 weeks. The patients was assessed prior to the treatment , then after 2 weeks and later after completion of 4 weeks. The tools for assessment include NPRS for pain, Quick-DASH for activity limitation of shoulder and goniometer for measuring range of motion of shoulder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scapular Dyskinesis
Keywords
Scapular dyskinesia, Scapular Clock Exercises, Open Heart Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There were 30 subjects divided equally and randomly into Group A and Group B. Group A was receive the intervention while group B will be active control group. The duration of treatment will be equal for both groups, that is 3 sessions per week for a period of 4 weeks.
Masking
Participant
Masking Description
Only the participants were masked. They did not know either they are in the interventional group or in the control group.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The interventional group received stretching and strengthening exercises along with scapular clock exercises. For the first two weeks, only scapular clock exercises were performed by the patient actively. After 2 weeks, the subjects performed scapular clock exercises by using the thera-band.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The active control group received stretching and strengthening exercises only. The stretching and strengthening exercises include corner stretch, wall-washes and pectoralis minor muscle stretch.
Intervention Type
Other
Intervention Name(s)
Scapular clock exercises
Other Intervention Name(s)
Stretching and strengthening exercises (Physical Therapy)
Intervention Description
In scapular clock exercises, the hand is placed on the wall in front of your body. Move the hand in direction of 12 and 6 o'clock to elevate and depress the scapula. Then move hands towards 9 o' clock and 3 o'clock direction to protract and retract the scapula. Hold each position for 10 seconds. From 3rd week and onward the patient will use thera-band and then perform clock exercises.
Intervention Type
Other
Intervention Name(s)
Stretching and strengthening exercises
Intervention Description
Stretching and strengthening exercises of shoulder and scapular muscles was performed including wall washes, corner stretch, pectoral muscles stretch and wall push ups.
Primary Outcome Measure Information:
Title
Shoulder pain
Description
Shoulder pain was assessed by using the Numeric Pain Rating (NPRS) Scale. NPRS is an 11-item Likert scale having 0 as no pain and 10 as maximum pain
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Level of Shoulder activity limitation
Description
The level of shoulder activity limitation was assessed by using the Quick-DASH questionnaire. There were 11 questions that were rated by the Likert scale having 1 as no disability and 5 as maximum disability
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Shoulder Range of Motion (ROM)
Description
Shoulder ROM will be assessed by using a Goniometer
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients whose open heart surgery is done at least 6weeks ago. Subjects having shoulder and scapular region pain. 50% or less loss of Active ROM of shoulder in abduction, flexion and external rotation. Positive Scapular assistance (SAT) and Scapular retraction test. Positive findings on observational examination of scapula, showing abnormal prominence of either inferior, medial or superior border of scapula. Type I and Type II scapular dyskinesia present Consented to take part in the study. Exclusion Criteria: • Bilateral shoulder involvement History of previous surgery on shoulder Shoulder fracture Glenohumeral or acromioclavicular joint Arthritis. Neuromuscular disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aqsa Shahid, Doctor of Physical Therapy
Phone
0301-8057342
Email
ladydocter48@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Zahir, Doctor of Physical Therapy
Phone
0306-6396683
Email
sanazahir22@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izza Ayub, MS Physical Therapy
Organizational Affiliation
The University of Faisalabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faisalabad Institute of Cardiology
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
34000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Zahir, Doctor of Physical Therapy
Phone
0306-6396683
Email
sanazahir22@gmail.com
First Name & Middle Initial & Last Name & Degree
Aqsa Shahid, Doctor of Physical Therapy
Phone
0301-8057342
Email
ladydocter48@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Scapular Clock Exercises in Scapular Dyskinesia in Post-Operative Open Heart Surgery Patients

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